FDA.reportPublic FDA data

Acetaminophen Extra Strength

Manufacturer
KROGER COMPANY | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2024-10-22
Label type
Human OTC Drug Label
Version
6
Source
full-release
Hydrated at
2026-06-01 00:28:36

Label at a glance#

ProductAcetaminophen Extra Strength
Active ingredientACETAMINOPHEN
Label structure16 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Storage and handling

store between 20° to 25°C (68° to 77°F). Avoid high humidity do not use if carton is open. Do not use if printed foil seal under cap is torn or missing

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each gelcap)

Acetaminophen USP 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F). Avoid high humidity
  • do not use if carton is open. Do not use if printed foil seal under cap is torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch (maize), propylene glycol, shellac glaze, sodium starch glycolate, talc and titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-632-6900
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 30142-068-07

Kroger®
              health

FOR ADULTS
EXTRA STRENGTH
 Acetaminophen
500 mg
PAIN RELIEVER/
FEVER REDUCER

24 RAPID RELEASE
GELCAPS
 500 mg EACH



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 30142-068-07

Kroger®
                health

COMPARE TO THE ACTIVE INGREDIENT IN
EXTRA STRENGTH TYLENOL® RAPID RELEASE GELS*
EXTRA STRENGTH            FOR ADULTS
Acetaminophen 500 mg
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

PAIN RELIEVER/
FEVER REDUCER

24 RAPID RELEASE
GELCAPS 500 mg EACH                    ACTUAL SIZE



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Carton)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (24 Gelcaps Container Carton)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN6
198440acetaminophen 500 MG Oral TabletSCD6
198440APAP 500 MG Oral TabletSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-068-07Acetaminophen Extra Strength1 in 1 CARTONTABLET16
30142-068-07Acetaminophen Extra Strength24 in 1 BOTTLETABLET246
30142-068-24Acetaminophen Extra Strength100 in 1 BOTTLETABLET1006
30142-068-24Acetaminophen Extra Strength1 in 1 CARTONTABLET16
30142-068-35Acetaminophen Extra Strength225 in 1 BOTTLETABLET2256
30142-068-35Acetaminophen Extra Strength1 in 1 CARTONTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-068ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [KROGER COMPANY]6Current NDC, Legacy NDC, 6 package rows20241024_b96a2280-ec4f-7c61-e053-2995a90a18bb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-06830142-068-07, 30142-068-35, 30142-068-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
AMMONIA5138Q19F1XIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 3PN2ZH5LOQYIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STARCH, CORNO8232NY3SJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Extra StrengthACETAMINOPHENKROGER COMPANYb96a2280-ec4f-7c61-e053-2995a90a18bb2024-10-22WarningsExact identifier
ndc (package): 30142-068-07
ndc (package): 30142-068-24
ndc (package): 30142-068-35
ndc (product): 30142-068
ndc11 (package): 30142006824
ndc11 (package): 30142006835
ndc11 (package): 30142006807
spl id: b65ad8d1-ef17-490d-96c0-0ea6096bf684
spl set id: b96a2280-ec4f-7c61-e053-2995a90a18bb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.